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While some studies have suggested that subumbilical and transumbilical incisions have a similar clinical efficiency and safety, no study has yet evaluated their respective impact on patient's postoperative aesthetic satisfaction.
The objective of this randomised trial is to compare patient's postoperative aesthetic satisfaction depending on the type of incision which is performed during surgeries.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Subumbilical incision | Other | The subumbilical incision was standardised. A curvilinear horizontal incision was performed to be able to reach the base of the umbilicus. The aponeurosis was incised with a scalpel and the peritoneal layer was open with a Kelly clamp. The incision was completed with the Hasson technique and a X-stitch was used for closure. |
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| Transumbilical incision | Other | The transumbilical incision was also standardised, inverting the umbilicus with graspers, then incising vertically the skin to reach the umbilical physiological hernia to enlarge it. The incision was also completed with the Hasson technique and a X-stitch was used for closure. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Transumbilical incision | Procedure | While both types of incision were considered equal regarding the potential clinical outcome, the investigators considered the transumbilical incision to be the ''intervention'' and the subumbilical incision to be the ''standard care comparator'' since the transumbilical incision take a few more minutes to be completed. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in postoperative patient's aesthetic satisfaction | An inverted 10 points Wong-Baker facial grimace-type scale was used to assess patient's satisfaction. Although the french version of our questionnaire was not validated, the concept behind Wong-Baker facial scale have been in various studies. In the case of this study, a 10 point score was associated with the highest possible satisfaction regarding the aesthetic appearance of the umbilicus. Patient's aesthetic satisfaction regarding the umbilicus was recorded preoperatively (right before the surgery), 1 month post-op and 6 months post-op. The change in postoperative patient's aesthetic satisfaction was assessed between pre-op vs 1 month post-op, pre-op vs 6 months post-op and 1 month vs 6 months post-op. | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Level of patient's awareness regarding the aesthetic appearance of the umbilicus | YES/NO (no meaning that the patient gives little to no importance to the aesthetic appearance of the umbilicus). Patient's level of importance regarding the aesthetic appearance of the umbilicus was recorded preoperatively (right before the surgery). | Pre-operative |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Nathalie McFadden, M.D | Centre de recherche du Centre hospitalier universitaire de Sherbrooke | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre Hospitalier Universitaire de Sherbrooke | Sherbrooke | Quebec | J1H 5N4 | Canada |
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| ID | Term |
|---|---|
| D017060 | Patient Satisfaction |
| D000072836 | Surgical Wound |
| ID | Term |
|---|---|
| D000074822 | Treatment Adherence and Compliance |
| D015438 | Health Behavior |
| D001519 | Behavior |
| D014947 | Wounds and Injuries |
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| Subumbilical incision | Procedure | Considered here as the ''control'' intervention. |
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